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Compositions useful for prevention and treatment of common cold and influenza-like symptomsRelated Patent Categories: Drug, Bio-affecting And Body Treating Compositions, Effervescent Or Pressurized Fluid Containing, Organic Pressurized FluidCompositions useful for prevention and treatment of common cold and influenza-like symptoms description/claimsThe Patent Description & Claims data below is from USPTO Patent Application 20070110676, Compositions useful for prevention and treatment of common cold and influenza-like symptoms. Brief Patent Description - Full Patent Description - Patent Application Claims
FIELD OF THE INVENTION [0001] The present invention is directed to compositions useful for the prevention and treatment of common cold and influenza-like symptoms due to respiratory tract viral infections, wherein these compositions are effective in preventing the onset of the symptoms of common cold and influenza or significantly mitigating them if an individual is already afflicted with such common cold and influenza-like symptoms BACKGROUND OF THE INVENTION [0002] It is known that many different viruses and viral strains result in symptoms associated with respiratory viral infections. The common cold is a complex syndrome caused by over 200 antigenically different viruses found in five virus families. These families include rhinovirus, myxovirus, paramyxovirus, respiratory syncytial virus, adenovirus and coronavirus. The most important group, with respect to the common cold, is rhinovirus, Gwaltney J. M., Common cold, pp 489-493, Mandell G. L., Douglas, R. G. Jr., Bennett, J. E., Principles and Practice of Infectious Diseases, 3rd ed., Churchill Livingstone, New York, 1990. Pinpointing the specific cause of the illness is difficult and not practical since there are also a number of predisposing factors whose contribution to the manifestation of symptoms is not fully understood. Such include, but are not limited to, physical fatigue, psychological stress, and overall physical health. [0003] Regardless of the virus and associated factors leading to the onset of common cold and influenza symptoms, a number of remedies to alleviate the symptoms of the common cold have been suggested. The cough/common cold products that are currently marketed typically contain one or more of the following actives: nasal decongestants such as pseudoephedrine or oxymetazoline, antihistamines such as doxylamine; antitussives such as dextromethorphan; expectorants such as guaifenesin; and anti-pyretics such as acetaminophen. In an attempt to improve existing common cold remedies, experts in the field have suggested several alternative pharmacotherapies and have conducted common cold trials to test their efficacy. Examples of these therapies include: the use of interferon, Douglas et al., Prophylactic Efficacy of Intranasal Alpha-Interferon Against Rhinovirus Infection in the Family Setting, The New England Journal of Medicine, 314, pp. 65-70, 1986; bradykinin antagonist, Higgins et al., A Study of the Efficacy of the Bradykinin Antagonist, NPC567; in Rhinovirus Infections in Human Volunteers, Antiviral Research vol. 14, pp. 339-344, 1990; glucocorticoid, Parr et al., A Randomized Controlled Trial of Glucocorticoid Prophylaxis Against Experimental Rhinovirus Infection, Journal of Infectious Diseases, vol. 162, pp. 1173-1177, 1990; nedocromil, Barrow et al., The Effect of Intranasal Nedocromil Sodium on Viral Upper Respiratory Tract Infections in Human Volunteers, Clinical and Experimental Allergy, vol. 20, pp. 45-51, 1990; a combination of interferon-.alpha..sub.2, ipratropium and naproxen, Gwaltney, Combined Antiviral and Antimediator Treatment of Rhinovirus Colds, The Journal of Infectious Diseases vol. 166, pp. 776-782, 1992; zinc salts, Potter et al., DIAS Rounds, Zinc Lozenges for Treatment of Common Colds, The Annals of Pharmacotherapy, vol. 27, pp. 589-592, 1993. [0004] A number of patents have also been issued disclosing compositions for prevention and treatment of the common cold and their methods of use. A sample of such patents includes: U.S. Pat. Nos. 5,240,694; 5,422,097; and 5,492,689; all to Gwaltney, disclosing treatment using; combinations of anti-viral and anti-inflammatory compounds; U.S. Pat. Nos. Re 33,465 and 5,409,905; both to Eby disclosing treatment using zinc salts; U.S. Pat. No. 5,626,831; to Van Moerkerken disclosing treatments using orally administered aminocarboxylic acid compounds; U.S. Pat. Nos. 4,619,934 and 4,552,899, both to Sunshine, disclosing treatment of cough and common colds using compositions comprising non-steroidal anti-inflammatory drugs such as NSAIDS with antihistaminically effective materials such as chlorpheniramine. Treatment for influenza includes vaccination and use of specific antiviral drugs. [0005] Amantidine and rimantidine have been used for treating influenza infections. They are reported to target the M2 protein of influenza virus and interfere with release of viral genetic material into the infected cell, thus preventing viral replication. A number of side effects have been reported including neurological and gastro-intestinal complaints, Beishe et al., Genetic basis of Resistance to Rimantidine Merging During Treatment of Influenza Virus Infection, Journal of Virology, 1988, 62, 1508-12; Hay, A. J., The Action of Adamantanamines Against Influenza A Viruses: Inhibition of the M2 Ion Channel, Protein. Semin Virol., 1992, 3, 21-30. [0006] Another approach to influenza treatment has been to inhibit the neuraminidase enzyme molecule on the virus, important to the virus' replication and infectivity. One such treatment drug is Zanamivir. See Robinson et al., "Zanamivir in the prevention of influenza among healthy adults: A randomized controlled trial," JAMA, 1999, 282, 31-5. Side effects reported were sinusitis, diarrhea, nausea, and adverse lung effects. A second neuraminidase inhibiting drug is Oseltamivir, licensed under the trade name Tamiflu. See Treanor et al., "Efficacy and safety of the oral neuraminidase inhibitor Oseltamivir in treating acute influenza: A randomized controlled study," JAMA, 2000, 283, 1016-24. There is a concern with Amantidine, Rimantidine and Neuraminidase inhibitors that viral resistance may develop, rendering them ineffective, A. Elliot and J. Ellis, 2000, Pharmaceutical Journal, 265, 446-451. [0007] U.S. Pat. No. 4,689,223, issued Aug. 25, 1987, assigned to T&R Chemicals, discloses nasal spray compositions for treating the symptoms of or preventing the common cold, wherein the compositions comprise sulphites or bisulphites having low pH, but no specific pH is disclosed. [0008] EP046409, published Feb. 24, 1982, to Walliczek, discloses processes for the preparation of solutions of cuprous complexes for therapeutic treatment of human or animal body. One disclosed process includes the preparation of cuprous complex with ascorbic acid or non toxic ascorbate having a pH from 4-6. The complex may be used to make solutions for topically treating fungal, inflammatory or viral complaints. Other disclosures of nasal compositions comprising viscous gels or other viscosity building polymeric materials include U.S. Pat. No. 4,891,226; WO 91/10434; U.S. Pat. No. 4,478,822; U.S. Pat. No. 5,599,534; U.S. Pat. No. 5,215,739; U.S. Published Application 2002/0032231; U.S. Pat. No. 6,365,624; U.S. Pat. No. 5,158,761; U.S. Pat. No. 5,897,858; and EP 1108422. [0009] Homeopathic ingredients, as specified in the Homeopathic Pharmacopeia of the U.S. and other compendia, have been evaluated in the treatment of the common cold, but with questionable success. One of the homeopathic ingredients most exhaustively studied is Echinacea. Various other non-homeopathic herbal and plant-derived compounds have been studied as well. [0010] A known characteristic of rhinoviruses is that they lose infectivity under acidic conditions. Even pH values of 5.0 are known to reduce Rhinovirus infectivity, Hughes, J. H., Acid Lability of Rhinovirus Type 14: Effect of pH, Time and Temperature, Proc. Soc. Exp. Biol. Med., 1993, 144, 555-60. EP310317, published Apr. 5, 1989 to Bordt et al., assigned to Beecham, discloses a method for inactivating viruses and bacteria with pharmaceutical compositions including vaccines prepared by inactivating viruses or bacteria with ascorbic acid or its salts in the presence of oxygen and heavy metal ions. U.S. Pat. No. 4,767,788, Diana, issued Aug. 30, 1988, assigned to Sterling Drug Inc., discloses processes for destroying viruses with glutaric acid including rhinovirus in the nasal mucosa. [0011] Therefore, although a low pH vehicle can potentially provide efficacy benefits to the delivery of medicaments, including homeopathic, allopathic or herbal drugs in the treatment of upper respiratory tract conditions, there are drawbacks to the aesthetic and pharmaceutical formulations of such vehicles. The low pH of the vehicle can produce irritation in the nasal cavity upon application. This effect may lead to reduced patient compliance and hence diminished efficacy of the formulation. Moreover, typical preservative systems for liquids are most effective at near neutral pH. Hence there are difficulties in maintaining the microbial integrity of low pH vehicles in addition to the perceived irritation of the nasal cavity. [0012] Despite the abundance of treatments known in the art, there remains a need to provide a consistent and effective method for prevention or treatment of common cold or influenza-like symptoms. There also remains a need to provide compositions, particularly nasal compositions, that are highly effective in the prevention or treatment of common cold and influenza-like symptoms, wherein the compositions comprise a delivery vehicle that optimizes the efficacy of the medicaments for the improved prevention or treatment of these common cold and influenza-like symptoms. SUMMARY OF THE INVENTION [0013] The present invention is directed to compositions useful for the prevention and treatment of common cold and influenza-like symptoms due to respiratory tract viral infections, wherein these compositions are effective in preventing the onset of the symptoms of common colds and influenza or significantly mitigating them if an individual is already afflicted with such symptoms. [0014] In one embodiment herein, the invention is directed to compositions comprising a guaiacol component and a mucoadhesive polymer wherein the composition has a pH of about 5.5 or less. [0015] In another embodiment herein, the invention is directed methods of treating or preventing a symptom associated with common cold or influenza in a mammal in need of such treatment or prevention, comprising administering to the mammal a composition comprising a guaiacol component and a mucoadhesive polymer, wherein the composition has a pH of about 5.5 or less. The subject mammal is a human, dog, cat, horse, goat, or any mammal that can be affected by the common cold, infected with influenza, or suffer from cold or influenza-like symptoms. [0016] These and other aspects of the present invention are described in further detail herein. DETAILED DESCRIPTION OF THE INVENTION [0017] Various documents including, for example, publications and patents, are recited throughout this disclosure. All such documents are hereby incorporated by reference. [0018] All percentages and ratios are calculated by weight unless otherwise indicated. All percentages and ratios are calculated based on the total composition unless otherwise indicated. [0019] Referenced herein are trade names for components including various ingredients utilized in the present invention. The inventors herein do not intend to be limited by materials under a certain trade name. Equivalent materials (e.g., those obtained from a different source under a different name or reference number) to those referenced by trade name may be substituted and utilized in the descriptions herein. [0020] In the description of the invention various embodiments or individual features are disclosed. As will be apparent to the ordinarily skilled practitioner, all combinations of such embodiments and features are possible and can result in preferred executions of the present invention. Continue reading about Compositions useful for prevention and treatment of common cold and influenza-like symptoms... 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